510(k) K260909
K260909 is an FDA 510(k) premarket notification submitted by Sienco, Inc. for the device "Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)". The FDA issued a decision of Substantially Equivalent on Oct 27, 2026. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Sienco, Inc. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 2026
- Date Received
- Mar 19, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type
- 510(k)